Perspective: Policies must keep pace with genetic progress

[Guest guest]

Perspective: Policies must keep pace with genetic progress

http://www.eurekalert.org/pub_releases/2008-06/gpp-ppm061908.php

Enactment of the Genetic Information Nondiscrimination Act (GINA) of

2008 is a boon to individual patients and for genetic research, write

Kathy Hudson, M.K. Holohan, and Francis in the June 19 issue

of the New England Journal of Medicine. But the bill is not a

panacea, they note: Employers, health insurers, patients, and doctors

now must be educated about its provisions, gaps remain in genetic

testing oversight, and there still may be opportunities to misuse

genetic information.

Hudson, director of the Pew Charitable Trusts-funded Genetics and

Public Policy Center, and co-authors Holohan and of the

National Human Genome Research Institute, reflect on GINA's slow path

through the legislative process. " When the first federal legislation

to prevent the misuse of genetic information was introduced in 1995,

many in the health care, research, and policy communities considered

the measure forward-looking. Others called it premature, " they write.

Thirteen years later, they note, " With many of these tests becoming

available in the clinic and some even being offered directly to

consumers, GINA's protections could no longer be dismissed as

premature; they were rapidly coming to seem essential to Americans'

ability to make the most of the much-anticipated era of personalized

medicine. "

After spending years stalled in committees, GINA finally passed the

House and Senate this spring with overwhelming bipartisan support,

and was signed into law by President Bush on May 21. The bill

prevents health insurers from denying coverage or setting premium

rates based on genetic information, and employers from making hiring,

firing, or promotion decisions based on a person's genes.

The authors quote Sen. Kennedy, who called GINA " the first

major new civil rights bill of the new century. " Kennedy was one of

the bill's lead sponsors. " Discrimination in health insurance and the

fear of potential discrimination threaten both society's ability to

use new genetic technologies to improve human health and the ability

to conduct the very research we need to understand, treat, and

prevent genetic disease, " he said.

GINA removes roadblocks in both health care delivery (because

patients can take genetic tests without fear of reprisal) and

research (because potential participants can be assured of the

security of their genetic information), the authors explain. However,

there are still regulatory steps to be taken to ensure genetic

information is used wisely. " [F]ederal agencies must write the

implementing regulations that will provide detailed guidance for

health insurers and employers about how to comply with the new law, "

the authors point out. Additionally, " We need to make certain that

health care professionals and patients understand the new

protections. "

Besides discrimination, another challenge to genomic medicine is

that " There are important gaps in the oversight of genetic tests, and

multiple advisory groups have called for regulatory reform to ensure

the analytic and clinical validity of genetic tests, " the authors

write. Finally, they note, " GINA addresses only employment and health

insurance, not life insurance, disability insurance, or long-term

care insurance… It may well be time for a thoughtful evaluation of

these other realms that are likely to be touched by the swift advance

of genomic science. "